BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 4354339 · Received December 22, 2014

    Report

    Report Number
    3008203003-2014-00080
    Event Type
    Injury
    Date Received
    December 22, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    BIOSENSE WEBSTER (ISRAEL) LTD.
    Product Code
    DQK
    PMA / PMN Number
    K133916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DHR REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. CONCOMITANT PRODUCTS: UNK. (B)(4). THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED. THE BS ECG CABLES WERE REPLACED AND THE ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE THAT UTILIZED A CARTO 3 SYSTEM AND SUFFERED A VENTRICULAR TACHYCARDIA. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE ECG SURFACE HAD DISAPPEARED FROM THE CARTO 3 SYSTEM DISPLAY. MULTIPLE SYSTEM ERRORS WERE GENERATED, SOME OF WHICH INDICATED THAT THE SYSTEM SHOULD BE SHUT DOWN AND SOME LINKED TO BODY SURFACE (BS) ECG RECORDINGS. ALTHOUGH MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THUS, IT IS NOT CLEAR FROM ALL FOLLOW-UPS PERFORMED, HOW, WHY OR WHEN THE PATIENT SUFFERED A VENTRICULAR TACHYCARDIA. THE AWARENESS DATE FOR THIS COMPLAINT WAS RESET TO (B)(4) 2014, THE DATE WE WERE MADE AWARE THAT THE PATIENT SUFFERED A VENTRICULAR TACHYCARDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841938 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other